Multidisciplinary Approach to Fatigue
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-39
SponsorJules Bordet Institute
About this trial
Prospective longitudinal, single-center, non-randomized study for the implementation of an integrated multidisciplinary fatigue follow-up for young patients with breast cancer or germ cell tumour
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 39 years at the time of signing the informed consent
Patient who speaks and understands French
Signed study informed consent form obtained prior to any study related procedures
At minimum, a moderate (>3) fatigue level according to the Standard Rating Scale (NRS) 1 month after completion of acute treatment; as measured at the Survivorship of the standard program
Disqualifiers
Refusal to participate in the study
Patient having chosen to participate in another psychosocial intervention study for the duration of the study.
Patients with AJCC stage IV breast cancer
Trial design
Design model
Single group
Treatments tested in this trial
Ergospirometry
Other interventionMaximum aerobic capacity (VO2 max), Maximum load, Ventilatory threshold and the patient's RQ
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Specific fatigue management programOther 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the feasibility of the specific fatigue management program
Rate of participation The program will be considered feasible for a given patient if he/she participates in a minimum of 70% of the 70% of the sessions/activities defined in their particular program
Time frame
Through study completion, an average of 4 yearsSecondary outcomes
1
The measurement of the evolution of the intensity of residual fatigue in the months following acute cancer treatment(s) before and after the specific fatigue management program
Numerical Rating Scale (NRS) for fatigue
Time frame
At the time of multidisciplinary screening and at 1, 3, 6, 12 and 18 months after completion of the specific fatigue management program.Sponsors and contacts
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Source ClinicalTrials.gov